A Digital Intervention Protocol to Enhance Recovery After Head and Neck Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Mean daily opioid use
研究概览
简要总结
This trial studies examines the impact of virtual reality (VR) experiences and Fitbit wearable activity devices on postoperative recovery after head and neck surgery. Virtual reality has shown to help rehabilitation and pain control primarily in non-surgical fields, and researchers are interested in using this to help postoperative pain control. Early mobilization after surgery is also important, and may increase lung capacity, improve gastrointestinal function, reduce pain, and reduce risk of deep venous thrombosis. Use of virtual reality and Fitbit devices may improve postoperative pain control and reduce narcotic use among hospitalized patients after head and neck surgery.
详细描述
PRIMARY OBJECTIVES:
I. Evaluate the effectiveness of daily virtual reality (VR) therapy during hospitalization, compared to patients not utilizing daily VR therapy.
II. Evaluate the effectiveness of daily ambulation goals using Fitbit devices during hospitalization, compared to patients without daily ambulation goals.
III. Evaluate the effectiveness of daily VR use and daily Fitbit ambulation goals during hospitalization.
EXPLORATORY OBJECTIVES:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •English speaking (Ability to interact with virtual reality content may be impacted by inability to understand English)
- •Older than 18 years of age and younger than 89 years of age. Both men and women and members of all races and ethnic groups will be included
- •Planned to undergo major surgery at Oregon Health & Science University (OHSU) with the Department of Otolaryngology-Head and Neck Surgery with an expected length of stay (LOS) of 2 days or more
- •Ability to understand and the willingness to sign a written informed consent document
排除标准
- •Planned postoperative admission to the intensive care unit (ICU)
- •Social or psychiatric conditions that may interfere with compliance
- •Isolation precautions
- •Complex head and neck procedure requiring resection or reconstruction involving the scalp, orbit, or mid-face. This would limit the ability to utilize the VR headset
- •Reconstruction, incisions, wounds, wound care, or injury that impact the ability to place on the VR headset or wear a Fitbit device around the wrist. This would limit the ability to utilize the VR headset or the Fitbit device
- •History of seizure or epilepsy
- •History of vertigo or persistent dizziness
- •Use of cardiac pacemaker, requirement for hearing aid on at all times, or have defibrillators
- •Limitations that impair mobility. This would limit the ability to utilize the Fitbit device
- •Use of a walker or wheelchair at baseline. This would limit the ability to utilize the Fitbit device
- •Pregnant women
- •Neonates of uncertain viability or nonviable neonates
- •Decisionally impaired adults
- •Prisoners
结局指标
主要结局
Mean daily opioid use
时间窗: Through study completion, an average of 10 days
Will be assessed using milligram morphine equivalents (MME). Narcotic use may be compared using One-Way Analysis of Variance (ANOVA) and two sample t-test can be used to compare the narcotic use between intervention group and control group (virtual reality \[VR\]+Fitbit versus \[vs.\] control, VR vs. control, Fitbit vs. control). Furthermore, a linear regression model including demographic and clinical characteristic variables with a P-value =\< 0.1 will be used to determine factors associated with reduced narcotic use.
次要结局
未报告次要终点
研究者
Ryan Li, MD
Principal Investigator
OHSU Knight Cancer Institute